Internet-Based Motivational Interviewing for Colonoscopy

NCT03595904 | Completed Results

• 2 other identifiers: GCO 14-0275K07CA190726
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Compared to other racial groups, African Americans have the highest colorectal cancer (CRC) morbidity and mortality rates. Although colonoscopies can prevent CRC, nearly one third of African Americans have not received a screening colonoscopy within the recommended time frame (one colonoscopy per ten years). It is critical to increase African Americans' screening colonoscopy rates in order to reduce racial inequities in CRC morbidity and mortality. Previous research suggests that a motivational interviewing based intervention may help improve screening colonoscopy uptake. This study will conduct a randomized clinical trial examining the efficacy of a motivational interviewing informed tablet app, called e-Motivate, to improve African Americans' screening colonoscopy uptake. Participants will be African Americans who receive a referral for a screening colonoscopy. Participants (N=200) will be randomly assigned to one of two groups: (1) usual care group (N=100); or (2) e-Motivate app group (N=100). Participants in the usual care group will receive standard clinical care which includes patient navigation (e.g., scheduling, reminder calls). Participants in the e-Motivate group will complete the e-Motivate app in the clinic immediately after they receive a referral for the screening colonoscopy. The participants in the e-Motivate app group will also receive usual care. Six months following the initial referral, participants' medical charts will be reviewed to determine whether the participants completed the recommended screening colonoscopy. Secondary outcomes (e.g., bowel prep quality, number of cancellations) will also be analyzed.

Conditions

Colorectal Neoplasms

Keywords

colorectal neoplasms; colonoscopy; African Americans; Telemedicine

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Completed a Screening Colonoscopy

  Six months following the initial referral, medical charts was reviewed to determine whether the participant completed the recommended screening colonoscopy

  six months after the initial referral

Secondary Outcomes (4)

• Number of Participants With Adequate Bowel Prep Quality

  six months after initial referral

• Number of Participants Who Had Canceled Appointments

  six months

• Number of Patients Who Had Rescheduled Appointments

  six months

• Number of Participants Who Were No-show Appointments

  six months

Study Arms (2)

E-Motivate group

EXPERIMENTAL

Participants complete a 20-minute tablet app, called e-Motivate, and receive usual care.

Behavioral: E-Motivate group

Usual Care Group

ACTIVE COMPARATOR

Participants in the usual care group will receive standard clinical care for patients referred for a screening colonoscopy

Behavioral: Usual Care Group

Interventions

E-Motivate group BEHAVIORAL

Participants in the e-Motivate group will receive standard clinical care which includes patient navigation (e.g., scheduling and reminders). They will also complete a 20-minute, motivational interviewing informed tablet app in the clinic immediately after they receive a referral for a screening colonoscopy. The tablet app consists of educational videos, interactive exercises (e.g., decisional balance), and personalized feedback (e.g., print summary).

E-Motivate group

Usual Care Group BEHAVIORAL

Participants in the usual care group will receive standard clinical care for patients referred for a screening colonoscopy. In particular, they will receive patient navigation which includes scheduling the colonoscopy appointment, making reminder calls, and providing print materials regarding the bowel prep instructions.

Usual Care Group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• self-identified as African American/Black
• received a referral for a screening colonoscopy
• recommended age to begin screening for colorectal cancer (based on current guidelines)
• English speaking

You may not qualify if:

• hearing or vision impaired
• participated in the previous iterative field testing

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai and Mount Sinai Hospital

New York, New York, 10029, United States

Location

Related Publications (1)

• Miller SJ, Foran-Tuller K, Ledergerber J, Jandorf L. Motivational interviewing to improve health screening uptake: A systematic review. Patient Educ Couns. 2017 Feb;100(2):190-198. doi: 10.1016/j.pec.2016.08.027. Epub 2016 Aug 26.

  PMID: 27599713 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Limitations and Caveats

There was notable missing data in the "bowel prep quality" outcome. Not all medical records included a bowel prep quality score. The control condition had 15 missing bowel prep quality ratings and the app condition had 7 missing bowel prep quality ratings. Furthermore, there were inconsistencies in the way in which bowel prep quality was reported (e.g., adequate/inadequate vs. poor, fair, good, excellent).

Results Point of Contact

• Title: Dr. Sarah Miller
• Organization: Icahn School of Medicine at Mount Sinai

Sarah.Miller@mssm.edu

212-824-7783

Study Officials

• Sarah Miller, PsyD

  Icahn School of Medicine at Mount Sinai and Mount Sinai Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded to the participants' assigned study group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants are randomly assigned to one of two groups (1:1).

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: July 23, 2018
• Study Start: November 20, 2017
• Primary Completion: May 8, 2020
• Study Completion: May 8, 2020
• Last Updated: July 8, 2021
• Results First Posted: July 8, 2021

Record last verified: 2021-06

Locations

US (1)